Viewing Study NCT02299219



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Last Modification Date: 2024-10-26 @ 11:34 AM
Study NCT ID: NCT02299219
Status: COMPLETED
Last Update Posted: 2019-10-09
First Post: 2014-11-17

Brief Title: Teens Taking Charge Managing Cancer Online
Sponsor: The Hospital for Sick Children
Organization: The Hospital for Sick Children

Study Overview

Official Title: Teens Taking Charge A Pilot Randomized Controlled Trial of an Online Self-Management and Transitional Care Program for Youth With Cancer
Status: COMPLETED
Status Verified Date: 2019-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Cancer is the most common potentially fatal disease of adolescence and the Internet represents an ideal means to deliver education self-monitoring capabilities and social support to enhance disease self-management by adolescents with cancer While two interactive coping websites exist for young people with cancer they are 1 not interactive 2 do not focus on helping youth gain skills for transition and independence and 3 do not provide opportunities for meaningful social support In summary there is a crucial need to develop a comprehensive interactive Internet-based self-management program targeting AWC that is comprised of cancer education self-management skills and opportunities for social support and that is cost-effective
Detailed Description: Overall aim of this program of research is to develop and evaluate the Teens Taking Charge Managing Cancer Online Internet intervention that will help AWC to better cope with their disease improve their HRQL and enhance readiness to transition to adult health care using a sequential phased approach The first phase of this project has determined the self-management and transitional care needs of adolescents with cancer The second phase consisted of website development and usability testing to ensure the website is easy to use and understand and is efficient and satisfying to complete Subsequently we will assess the feasibility of the program and the outcomes from the use of the site in a randomized controlled trial RCT pilot study Phase 3 This will inform the design and methods of the main trial and will permit us to obtain estimates of treatment effects on AWC health outcomes to inform the calculation of an appropriate sample size for the future definitive RCT Phase 4 The focus of this study is Phase 3 Phase 4 will be a multicentre randomized controlled trial to assess outcomes for teens that complete the intervention as compared to those of an attention control group

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None